drugset / Trial / NCT01861730
Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants
Phase 1/2
Completed
243 enrolled
Aeras
International Maternal Pediatric Adolescent AIDS Clinical Trials Group · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabSanofi Pasteur, a Sanofi Company · collabStatens Serum Institut · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and dose-range finding study of AERAS-404 Tuberculosis (TB) vaccine administered intramuscularly in Bacille Calmette-Guerin (BCG) primed infants.
Timeline
- Start
- 2013-07-01
- Primary completion
- 2017-12-22
- Completion
- 2017-12-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AERAS-404 | Vaccine | 5 ug | Intramuscular |
| Subject | AERAS-404 | Vaccine | 15 ug | Intramuscular |
| Subject | AERAS-404 | Vaccine | 50 ug | Intramuscular |
| Subject | IC31 | Other / unclassified | 100 unknown | Intramuscular |
| Subject | IC31 | Other / unclassified | 500 unknown | Intramuscular |